Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections
Bacterial endocarditis
Bacterial meningitis
Endocarditis - prophylaxis
Group B streptococcal infection

Amoxicillin is a broad spectrum aminopenicillin antibiotic indicated for the treatment of commonly occurring bacterial infections. Infections include:

Upper respiratory tract infections: mouth infection, sinusitis.

Lower respiratory tract infections: acute and chronic bronchitis, chronic bronchial sepsis, pneumonia

Anthrax infection

Ear infections: otitis media

Genitourinary infections: cystitis, urethritis, pyelonephritis, bacteriuria during pregnancy, gonorrhoea, gynaecological infections including puerperal sepsis and septic abortion.

Gastrointestinal infections: biliary tract infection, Escherichia coli enteritis, Salmonella enteritis, gastroenteritis, typhoid fever, paratyphoid fever, Helicobacter pylori infection

Bone and joint infections

Skin and soft tissue infections: actinomycosis

Other: septicaemia, intra-abdominal sepsis, peritonitis, bacterial endocarditis, adjunct therapy for bacterial meningitis

Amoxicillin is also indicated for the prophylaxis of endocarditis.

Not all brands are licensed for all indications.

Administration

For intramuscular injection, intravenous injection or intravenous infusion only.

Contraindications

None known

Precautions and Warnings

Allergic disposition
Cytomegalovirus infection
Infectious mononucleosis
Neonates
Premature infants
Restricted sodium intake
Lymphatic leukaemia
Oliguria
Positive HIV status
Renal impairment

Jarisch-Herxheimer reaction possible in treatment of syphilis
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all indications
Administer reconstituted solution immediately
Avoid contact of product with skin
Maintain hydration and urinary output
Monitor for signs of superinfection with non-susceptible organisms
Monitor haematological status during prolonged and high dose therapy
Monitor patency of urinary catheters regularly, precipitation may occur
Monitor renal function during prolonged/high dose therapy
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if overgrowth of resistant organisms occurs

Not all brands are licensed for all indications and dosage regimens may vary.

Amoxicillin should be given with caution to patients with a history of allergy, especially to drugs. Desensitisation may be required if treatment is essential.

Caution is advised when very high doses of amoxicillin are administered, especially if renal function is poor, due to the risk of nephrotoxicity. Care is also necessary if large doses of sodium (as amoxicillin sodium) are given to patients with impaired renal function or cardiac failure. Renal and haematological status should be monitored during prolonged and high-dose therapy.

Crystalluria has been observed rarely in patients with reduced urine output. At high doses adequate fluid intake and urinary output must be maintained in order to reduce the possibility of crystalluria.

Amoxicillin should not be used in patients with underlying urinary tract defects or for the long-term treatment of recurrent urinary tract infections. This is because resistance may develop in the enteric flora.

In children with a urinary tract infection, the need for further clinical investigation should be considered.

Care should be taken with the use of amoxicillin in premature children and during the neonatal period and the renal, hepatic and haematological functions should be monitored.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Amoxicillin may affect glucose testing in urine.

Pregnancy and Lactation

Pregnancy

There is no evidence that amoxicillin has a teratogenic effect, and its suitability for use during pregnancy has been well documented in clinical studies. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 3546 of whom had first trimester exposures to penicillin derivatives. For use at anytime during pregnancy, 7171 exposures were recorded, in neither group was evidence found to suggest a relationship to large categories of major or minor malformations or to individual defects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Amoxicillin may be given during breast feeding.

With the exception of possible sensitisation associated with the excretion of trace amounts of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant. Studies have shown that less than 0.95% of the maternal dose is excreted into human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute generalised exanthematous pustulosis
Agranulocytosis
Allergic reaction
Anaphylaxis
Angioneurotic oedema
Antibiotic-associated colitis
Bullous dermatoses
Candida mucocutaneous
Cholestatic jaundice
CNS toxicity
Convulsions
Crystalluria
Diarrhoea
Dizziness
Electrolyte disturbances
Erythema multiforme
Exfoliative dermatitis
Fever
Haemolytic anaemia
Haemorrhagic colitis
Hepatitis
Hyperkinesia
Hypersensitivity reactions
Impaired platelet function
Increase in serum ALT/AST
Interstitial nephritis
Joint pain
Leucopenia
Maculopapular rash
Nausea
Neutropenia
Prolonged bleeding
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vasculitis (allergic)
Vomiting

Presentation

Powder for solution for injection containing amoxicillin

Drugs List

Therapeutic Indications

Uses

Antibiotic sensitive infections
Bacterial endocarditis
Bacterial meningitis
Endocarditis - prophylaxis
Group B streptococcal infection

Amoxicillin is a broad spectrum aminopenicillin antibiotic indicated for the treatment of commonly occurring bacterial infections. Infections include:

Upper respiratory tract infections: mouth infection, sinusitis.

Lower respiratory tract infections: acute and chronic bronchitis, chronic bronchial sepsis, pneumonia

Anthrax infection

Ear infections: otitis media

Genitourinary infections: cystitis, urethritis, pyelonephritis, bacteriuria during pregnancy, gonorrhoea, gynaecological infections including puerperal sepsis and septic abortion.

Gastrointestinal infections: biliary tract infection, Escherichia coli enteritis, Salmonella enteritis, gastroenteritis, typhoid fever, paratyphoid fever, Helicobacter pylori infection

Bone and joint infections

Skin and soft tissue infections: actinomycosis

Other: septicaemia, intra-abdominal sepsis, peritonitis, bacterial endocarditis, adjunct therapy for bacterial meningitis

Amoxicillin is also indicated for the prophylaxis of endocarditis.

Not all brands are licensed for all indications.

Dosage

Dosage will depend on the severity and nature of the infection.

Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

Adults

Children

Neonates

Patients with Renal Impairment

Administration

For intramuscular injection, intravenous injection or intravenous infusion only.

Contraindications

None known

Precautions and Warnings

Allergic disposition
Cytomegalovirus infection
Infectious mononucleosis
Neonates
Premature infants
Restricted sodium intake
Lymphatic leukaemia
Oliguria
Positive HIV status
Renal impairment

Jarisch-Herxheimer reaction possible in treatment of syphilis
Before initiating therapy enquire about previous hypersensitivity reactions
Consult national/regional policy on the use of anti-infectives
Not all available brands are licensed for all indications
Administer reconstituted solution immediately
Avoid contact of product with skin
Maintain hydration and urinary output
Monitor for signs of superinfection with non-susceptible organisms
Monitor haematological status during prolonged and high dose therapy
Monitor patency of urinary catheters regularly, precipitation may occur
Monitor renal function during prolonged/high dose therapy
Erythematous rash common in glandular fever, CMV inf, lymphocytic leukaemia
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Discontinue if drug-related rash or other hypersensitivity reactions occur
Discontinue if overgrowth of resistant organisms occurs

Not all brands are licensed for all indications and dosage regimens may vary.

Amoxicillin should be given with caution to patients with a history of allergy, especially to drugs. Desensitisation may be required if treatment is essential.

Caution is advised when very high doses of amoxicillin are administered, especially if renal function is poor, due to the risk of nephrotoxicity. Care is also necessary if large doses of sodium (as amoxicillin sodium) are given to patients with impaired renal function or cardiac failure. Renal and haematological status should be monitored during prolonged and high-dose therapy.

Crystalluria has been observed rarely in patients with reduced urine output. At high doses adequate fluid intake and urinary output must be maintained in order to reduce the possibility of crystalluria.

Amoxicillin should not be used in patients with underlying urinary tract defects or for the long-term treatment of recurrent urinary tract infections. This is because resistance may develop in the enteric flora.

In children with a urinary tract infection, the need for further clinical investigation should be considered.

Care should be taken with the use of amoxicillin in premature children and during the neonatal period and the renal, hepatic and haematological functions should be monitored.

The Faculty of Sexual and Reproductive Health has issued revised guidance concerning additional contraceptive cover when antibiotics are prescribed to patients taking combined oral contraceptives in January 2011. With the exception of the enzyme-inducing antibiotics rifampicin and rifabutin, it is no longer necessary to advise the patient to take additional contraceptive precautions while also taking an antibiotic.

Advise the patient that if vomiting occurs, she should follow the guidance for the oral contraceptive in respect of additional doses or contraceptive precautions.

Amoxicillin may affect glucose testing in urine.

Pregnancy and Lactation

Pregnancy

There is no evidence that amoxicillin has a teratogenic effect, and its suitability for use during pregnancy has been well documented in clinical studies. The Collaborative Perinatal Project monitored 50,282 mother-child pairs, 3546 of whom had first trimester exposures to penicillin derivatives. For use at anytime during pregnancy, 7171 exposures were recorded, in neither group was evidence found to suggest a relationship to large categories of major or minor malformations or to individual defects.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Amoxicillin may be given during breast feeding.

With the exception of possible sensitisation associated with the excretion of trace amounts of amoxicillin in breast milk, there are no known detrimental effects for the breast-fed infant. Studies have shown that less than 0.95% of the maternal dose is excreted into human milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Acute generalised exanthematous pustulosis
Agranulocytosis
Allergic reaction
Anaphylaxis
Angioneurotic oedema
Antibiotic-associated colitis
Bullous dermatoses
Candida mucocutaneous
Cholestatic jaundice
CNS toxicity
Convulsions
Crystalluria
Diarrhoea
Dizziness
Electrolyte disturbances
Erythema multiforme
Exfoliative dermatitis
Fever
Haemolytic anaemia
Haemorrhagic colitis
Hepatitis
Hyperkinesia
Hypersensitivity reactions
Impaired platelet function
Increase in serum ALT/AST
Interstitial nephritis
Joint pain
Leucopenia
Maculopapular rash
Nausea
Neutropenia
Prolonged bleeding
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Rash
Serum sickness-like reactions
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Urticaria
Vasculitis (allergic)
Vomiting

Effects on Laboratory Tests

It is recommended that when testing for the presence of glucose in urine during amoxicillin treatment, enzymatic glucose oxidase methods should be used. Due to the high urinary concentrations of amoxicillin, false positive readings are common with chemical methods.

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: October 2013

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Amoxil Vials for Injection 500mg. GlaxoSmithKline UK. Revised January 2012.
Summary of Product Characteristics: Amoxil Vials for Injection 1g. GlaxoSmithKline UK. Revised January 2012.
Summary of Product Characteristics: Amoxicillin Sodium for Injection. Wockhardt UK Ltd. Revised June 2010.

Faculty of Sexual and Reproductive Healthcare
https://www.ffprhc.org.uk/pdfs/CEUGuidanceDrugInteractionsHormonal.pdf
Last accessed 7 october 2013

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 04 September 2017